ABSTRACT The Biostatistics Shared Resource provides clinical, translational, and scientific researchers at the Duke Cancer Institute (DCI) access to state-of-the-art expertise in biostatistics methods for study design, analysis, and reporting. The Resource's partnerships have embedded biostatistics teams in disease-specific clusters to provide ongoing development of research, grant applications, and clinical protocols. The Biostatistics Shared Resource is led by a newly recruited Director, Dr. Terry Hyslop. She oversees an expert cadre of 9 faculty and 11 staff who partner with DCI disease groups and Research Programs. While initially focused on translational research and clinical trials, the Resource is extending its embedding activities into other cancer research areas, such as health services research, observational studies, epidemiology, basic sciences, and others to meet the needs of the DCI. These partnerships have strengthened grant funding, high impact publications, and created an enhanced research-training environment at DCI. Dr. Hyslop and the Biostatistics Shared Resource also work closely with the DCI's Bioinformatics Shared Resource and Information Systems Shared Resource to establish appropriate breadth and range of expertise to meet DCI needs. Planning and oversight is provided by DCI administrative leadership and the DCI Shared Resources Oversight Committee. The Shared Resource was utilized in over 300 publications since the last review, with approximately 45-55 cancer-related publications per year, each year. There are roughly 119 active projects for 62 DCI investigators across a wide range of disease-sites and CCSG-recognized Research Programs. The Resource also participates in and co- leads the development and testing of appropriate systems for trial data management and linkages through Medidata Rave, Medidata Balance, RedCap, and other tools. It also provides assistance with clinical trial compliance, reporting, and oversight and provides scientific review of all DCI protocols.